# K192443: Dextile Anatomical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Sofradim Production
- Decided: Dec 6, 2019 after 91 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K091659 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091659: Bard 3DMAX Light Mesh, Models: 0117310, 0117311, 0117312, 0117320, 0117321, 011732, C.R. Bard, Inc. (2009) Summary page 4.

## Indications for use
Dextile Anatomical Mesh is intended to be used for the reinforcement of soft tissues where weakness exists during repair of inguinal hernia by laparoscopic approach.

Source page: https://510kreport.com/device/K192443
Methodology: https://510kreport.com/methodology